The authors make no claims of the accuracy of the information contained
herein; and these suggested doses and/or guidelines are not a substitute for clinical
judgment. Neither GlobalRPh Inc. nor any other party involved in the
preparation of this document shall be liable for any special,
consequential, or exemplary damages resulting in whole or part from any
user's use of or reliance upon this material. PLEASE
READ THE
DISCLAIMER CAREFULLY BEFORE
ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE
TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Drug: Oxaliplatin -
Eloxatin®

Usual Diluents

D5W

Dilution Data

DILUTION SUMMARY

[Amount of drug] [Infusion volume] [Infusion rate]

[Prescribed dose] [250 - 500ml D5W] [2 hours]

The
infusion line should be flushed with D5W prior to
administration of any concomitant medication. Concentration must be
between 0.2 to 0.7 mg/mL

Preparation of Infusion Solution
-----------------------------------------------------------------------1] Reconstitution of lyophilized powder
The lyophilized powder is reconstituted by adding 10 mL (for the 50 mg
vial) or 20 mL (for the 100 mg vial) of Water for Injection, USP or 5%
Dextrose Injection, USP. Do not administer the reconstituted solution
without further dilution.

Stability:
After reconstitution in the original vial, the solution may be stored up
to 24 hours under refrigeration [2º to 8°C (36º to 46° F)]. After final
dilution with 250 to 500 mL of 5% Dextrose Injection, USP, the shelf
life is 6 hours at room temperature [20º to 25°C (68º to 77°F)] or up to
24 hours under refrigeration [2º to 8°C (36º to 46°F)].

2] Concentrated solution preparation:
Do not freeze the concentrated solution.
A final dilution must never be performed with a sodium chloride solution or
other chloride-containing solutions.

The solution must be further diluted in an infusion solution of 250-500 mL of 5%
Dextrose Injection, USP.Usual infusion rate: 2 hours (range: 2 - 6 hours).
Concentration must be between 0.2 to 0.7 mg/mL.

After dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is
6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under
refrigeration [2-8°C (36-46°F)]. After final dilution, protection from light is
not required.

Oxaliplatin Injection is incompatible in solution with alkaline medications or
media (such as basic solutions of 5-fluorouracil) and must not be mixed with
these or administered simultaneously through the same infusion line.
The
infusion line should be flushed with 5% Dextrose Injection, USP prior to
administration of any concomitant medication.

Needles or intravenous administration sets containing aluminum parts that may
come in contact with Oxaliplatin Injection should not be used for the
preparation or mixing of the drug. Aluminum has been reported to cause
degradation of platinum compounds.

Stability / Miscellaneous

Administer Oxaliplatin Injection in combination with
5-fluorouracil/leucovorin every 2 weeks:

Day 1:
Oxaliplatin Injection 85 mg/m2
intravenous infusion in 250-500 mL 5% Dextrose
Injection, USP and leucovorin 200 mg/m2
intravenous infusion in 5% Dextrose Injection, USP
both given over 120 minutes at the same time in
separate bags using a Y-line, followed by
5-fluorouracil 400 mg/m2
intravenous bolus given over 2 to 4 minutes,
followed by 5-fluorouracil 600 mg/m2
intravenous infusion in 500 mL 5% Dextrose
Injection, USP (recommended) as a 22-hour continuous
infusion.

Never reconstitute or prepare final dilution with a sodium
chloride solution or other chloride-containing solutions.

WARNINGSANAPHYLACTIC REACTIONS
ANAPHYLACTIC REACTIONS to Oxaliplatin Injection have been reported, and
may occur within minutes of Oxaliplatin Injection administration.
Epinephrine, corticosteroids, and antihistamines have been employed to
alleviate symptoms of anaphylaxis [see PACKAGE INSERT FOR Warnings and Precautions (5.1)].

1. INDICATIONS AND USAGE
Oxaliplatin Injection, used in combination with infusional 5-fluorouracil/leucovorin,
is indicated for:

-
adjuvant treatment of stage III colon cancer in patients who have undergone
complete resection of the primary tumor.

-
treatment of advanced colorectal cancer.

2. DOSAGE AND ADMINISTRATION
Oxaliplatin Injection should be administered under the supervision of a
qualified physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when
adequate diagnostic and treatment facilities are readily available.

2.1 Dosage
Administer Oxaliplatin Injection in combination with 5-fluorouracil/leucovorin
every 2 weeks. For advanced disease, treatment is recommended until disease
progression or unacceptable toxicity.
For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):

Day 1: Oxaliplatin Injection 85 mg/m2 intravenous infusion in 250-500 mL 5%
Dextrose injection, USP and leucovorin 200 mg/m2 intravenous infusion in 5%
Dextrose Injection, USP both given over 120 minutes at the same time in separate
bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus
given over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous
infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour
continuous infusion.

The administration of Oxaliplatin Injection does not require prehydration.
Premedication with antiemetics, including 5-HT3 blockers with or without
dexamethasone, is recommended.
For information on 5-fluorouracil and leucovorin, see the respective package
inserts.

2.2 Dose Modification Recommendations
Prior to subsequent therapy cycles, patients should be evaluated for clinical
toxicities and recommended laboratory tests [see PACKAGE INSERT FOR Warnings and Precautions
(5.6)]. Prolongation of infusion time for Oxaliplatin Injection from 2 hours to
6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and
leucovorin do not need to be changed.

Adjuvant Therapy in Patients with Stage III Colon Cancer:

Neuropathy and other toxicities were graded using the NCI CTC scale version 1
[see Warnings and Precautions (5.2)].

For patients who experience persistent Grade 2 neurosensory events that do not
resolve, a dose reduction of Oxaliplatin Injection to 75 mg/m2 should
be considered. For patients with persistent Grade 3 neurosensory events,
discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin
regimen need not be altered.

Neuropathy was graded using a study-specific neurotoxicity scale [see PACKAGE
INSERT FOR Warnings
and Precautions (5.2)]. Other toxicities were graded by the NCI CTC, Version
2.0.

For patients who experience persistent Grade 2 neurosensory events that do not
resolve, a dose reduction of Oxaliplatin Injection to 65 mg/m2 should be
considered. For patients with persistent Grade 3 neurosensory events,
discontinuing therapy should be considered. The 5-fluorouracil/leucovorin
regimen need not be altered.

-----------------------------------------------------------------------2.3 Preparation of Infusion Solution
-----------------------------------------------------------------------
Do not freeze the concentrated solution.

A final dilution must never be performed with a sodium chloride solution or
other chloride-containing solutions.

The solution must be further diluted in an infusion solution of 250-500 mL of 5%
Dextrose Injection, USP.

After dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is
6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under
refrigeration [2-8°C (36-46°F)]. After final dilution, protection from light is
not required.

Oxaliplatin Injection is incompatible in solution with alkaline medications or
media (such as basic solutions of 5-fluorouracil) and must not be mixed with
these or administered simultaneously through the same infusion line. The
infusion line should be flushed with 5% Dextrose Injection, USP prior to
administration of any concomitant medication.

Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration and discarded if present.

Needles or intravenous administration sets containing aluminum parts that may
come in contact with Oxaliplatin Injection should not be used for the
preparation or mixing of the drug. Aluminum has been reported to cause
degradation of platinum compounds.

3. DOSAGE FORMS AND STRENGTHS
Oxaliplatin Injection is supplied in single use vials containing 50 mg or 100 mg
of oxaliplatin as a sterile, preservative-free aqueous solution at a
concentration of 5 mg/mL.

4. CONTRAINDICATIONS
Oxaliplatin Injection should not be administered to patients with a history of
known allergy to Oxaliplatin Injection or other platinum compounds [see PACKAGE
INSERT FOR Warnings
and Precautions (5.1)].

How Supplied
Oxaliplatin Injection is supplied in clear, glass, single use vials containing
50 mg or 100 mg of oxaliplatin as a sterile, preservative-free aqueous solution
at a concentration of 5 mg/mL. Tartaric Acid, NF, Water for Injection, USP and
Sodium Hydroxide, NF are used as inactive ingredients and/or in combination as a
buffering system.

NDC 61703-363-18: 50 mg/10 mL single use vial individually packaged in a carton.

NDC 61703-363-22: 100 mg/20 mL single use vial individually packaged in a
carton.

Handling and Disposal
As with other potentially toxic anticancer agents, care should be exercised in
the handling and preparation of infusion solutions prepared from Oxaliplatin
Injection. The use of gloves is recommended. If a solution of Oxaliplatin
Injection contacts the skin, wash the skin immediately and thoroughly with soap
and water. If Oxaliplatin Injection contacts the mucous membranes, flush
thoroughly with water.

Procedures for the handling and disposal of anticancer drugs should be
considered. Several guidelines on the subject have been published. There is no general agreement that all of the procedures
recommended in the guidelines are necessary or appropriate.

Reference(s)

< Disclaimer >

The authors make no claims of the accuracy of the information contained
herein; and these suggested doses and/or guidelines are not a substitute for clinical
judgment. Neither GlobalRPh Inc. nor any other party involved in the
preparation of this document shall be liable for any special,
consequential, or exemplary damages resulting in whole or part from any
user's use of or reliance upon this material. PLEASE
READ THE
DISCLAIMER CAREFULLY BEFORE
ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE
TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.